亲水凝胶骨架材料制备盐酸多奈哌齐缓释片的可行性研究

Feasibility Study of Donepezil Hydrochloride Extended-release Tablets Prepared with Gel-forming Matrix Material

目的采用亲水凝胶骨架材料制备盐酸多奈哌齐缓释片,并对其质量进行评价。方法采用亲水凝胶骨架材料HPMC K100LV和K4M联用通过干法制粒工艺制备盐酸多奈哌齐缓释片,以溶出曲线相似性f2值作为评价指标,通过正交设计进行处方优化,用高效液相色谱法进行含量和杂质检测,通过加速和长期试验考察片剂稳定性。结果以该方法制备的盐酸多奈哌齐缓释片质量稳定,具有与原研制剂一致的溶出特征。结论以该方法制备盐酸多奈哌齐缓释片具有可行性。

OBJECTIVE To prepare donepezil hydrochloride extended-release tablets by hydrophilic gel-forming matrix materials and assess the quality. METHODS Combined with two types of hydrophilic gel-forming matrix material HPMC K100 LV and HPMC K4 M. Donepezil hydrochloride extended-release tablets were manufactured by the dry granulation process. The formulations were optimized by orthogonal experiment design utilizing dissolution similarity f2 as an evaluation index. The drug content and impurity were analyzed by the HPLC method. The stability study was conducted under an accelerated and long-term conditions. RESULTS The optimized formulation of donepezil hydrochloride extended-release tablets showed acceptable quality and stability and similar dissolution profiles with the brand product. CONCLUSION The prepared donepezil hydrochloride extended-release tablets are feasible.